Formulary Watch |

FDA Approves Treatment for Post-Transplant Infection

Livtencity is the first therapy approved to treat cytomegalovirus infection, which is common after transplants.

Large Study Finds Aduhelm Can be Associated with Brain Swelling

OptumRx Excludes the Diabetes Biosimilar Semglee from Formulary

Recent Generic Launches

Several new generics have launched in the United States, including for the migraine therapy Zomig, the anticancer therapy Doxil, and an anti-inflammatory used to treat respiratory conditions associated with COVID-19.

FDA Accepts for Priority Review Gene Therapy for Rare Blood Disorder

If approved, Bluebird Bio’s beti-cel would be the first one-therapy for β-thalassemia. The PDUFA date is May 20, 2022.

Long-term Study Shows Pfizer COVID-19 Vaccine is 100% Effective in Adolescents

Pfizer/BioNTech plan to use this data to support submissions for full approval of the vaccine in those 12 to 15 years old.

Sagent Recalls Four Lots of Levetiracetam

The antiseizure medication affected by the recall could have sterility issues.

Formulary Watch Drug Shortage Update — November 21, 2021

Gilead Submits BLA for Chronic Hepatitis Therapy

Bulevirtide has been granted breakthrough therapy and orphan drug designations by the FDA.

FDA Approves First Drug for a Form of Dwarfism

BioMarin’s Voxzogo is expected to be available in the United States by mid- to late-December.

FDA Expands EUA for Moderna and Pfizer COVID-19 Boosters

The boosters are now authorized for all people 18 years of age and older.

FDA Extends Review of Mavacamten to April 2022

Onco360 Chosen as a Specialty Pharmacy Provider for Besremi

Besremi was approved recently to treat a rare blood disease.

FDA Grants Approval to Keytruda for Early Stage RCC

Keytruda is the first immunotherapy approved for treatment of patients with early renal cell carcinoma after surgery.

Study: COVID-19 Booster Hikes Cancer Patients’ Antibodies

ICER: Humira Leads Drug Price Increases

Pfizer Seeks EUA for COVID-19 Oral Antiviral

If authorized, Paxlovid would be the first oral 3CL protease inhibitor specifically designed to combat the virus that causes COVID-19.

Biocon Launches Biosimilar Semglee

Branded and unbranded versions of the interchangeable biosimilar to treat patients with diabetes are now available.

Study: Medicare Part B Reimbursement Hinders Biosimilar Uptake

SterRx Recalls 240 Lots of 12 Products

Equipment and process issues could lead to a lack of sterility.

Formulary Watch Drug Shortage Update — November 14, 2021

FDA Approves Treatment for Rare Blood Disease

Besremi is the first interferon approved to treat a disease that causes the overproduction of red blood cells.

FDA Accepts Supplemental NDA for Jardiance

If approved, Jardiance would be the first treatment for adults across the full spectrum of heart failure regardless of ejection fraction.

Blood Cancer Patients at Risk of COVID-19 Breakthrough Cases

Survey: Health Plans Want Value, Flexibility from PBMs

FDA Updates Warning Labels for MS Products

Pfizer Submits EUA for COVID-19 Vaccine Booster for All Adults

Previously, the FDA had issued an EUA for those over the age of 65 and those at high risk for severe COVID-19 or exposure to the virus.

Study: Health Plans Use Restrictive Step Therapy Protocols

Half of the step therapy protocols for specialty drugs evaluated by investigators go beyond what is suggested in treatment guidelines.

FDA Approves Liquid Formulation of Seizure Medication

Eprontia is the first liquid formulation of topiramate approved to both treat and prevent seizure.

Pfizer’s COVID-19 Antiviral Cuts Hospitalization, Deaths